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Preservative Update

Facing a raft of challenges to traditional systems, industry suppliers have developed a fleet of solutions to meet marketers’ preservation needs.

Tom Branna
Editorial Director

Among the many classes of ingredients used in the formulation of household and personal products, few have undergone more scrutiny than preservatives. Whether the assault comes from ill-advised legislators, self-serving “natural product” marketers or chemophobic consumers, preservative suppliers have had to defend their product category with vigor and develop new systems when the market demands it.

“Consumers are becoming more aware of natural materials and companies are moving to respond to their demands,” said Rosita Nunez, Lonza’s preservative product development leader. “Ingre- dient lists are being scrutinized more closely by consumers and alternatives to ‘controversial’ ingredients are increasingly sought.”

In fact, preservative companies have proved to be quite agile at responding to the changing needs of household and personal care marketers. Nearly every supplier who spoke to Happi noted that their company has recently introduced paraben-free or even “natural” lines of preservatives.

“The widespread concern regarding preservatives and other cosmetic ingredients in the media spotlight has affected our business in a positive way,” insisted Body Blue’s Mike Hooper. “We have been working for the past four years to develop options for our clients, such as glycol-free deodorants and our alternative preservative system called Naturebak. As such, we are in a good position to respond to changing consumer needs based on the safety concerns that are receiving so much media attention.”

According to Mr. Hooper, Naturebak has been refined and expanded further during the past two years and Body Blue has produced tens of millions of personal care products using this technology. Furthermore, Body Blue is able to formulate custom formulations with Naturebak to the clients’ requirements using unpreserved raw materials.

“This enables clients to create products that are as free from questionable materials as possible,” said Mr. Hooper. “It was not an easy task to achieve, but now our clients can benefit from the years of hard work we have invested in this unique technology.”

“Many of our innovative new raw materials must be paraben-free, or the formulators will not even consider them for evaluation,” he noted.

To meet demands, TRI-K offers a full range of parabens and paraben-based products, and many paraben-free preservatives as well. The company’s newest line, Twincide (manufactured by Roda Research, Milan, Italy), is based on a patented combination of phenoxyethanol and benzyl PCA. According to Mr. Blinder, the Twincide range demonstrates strong preservative capabilities while offering moisturization effects to the skin as well, and is completely paraben-free.

Steve Hinden, director of business development at Arch Personal Care Products, agreed that the concerns expressed in the media and other scientific and regulatory authorities have created a major shift in the way companies view traditional preservative technologies, such as parabens, formaldehyde donors and isothiazolones. But he insisted that this shift has presented an unprecedented opportunity to address a fundamental change in consumer expectation and demand for new technology approaches.

“We’ve directed our resources to replace the popular parabens, formaldehyde donors and isothiazolones with systems that rely on alternative technologies,” said Mr. Hinden. “With the help of Arch’s R&D Center in Cheshire CT, two new patented products, Mikrokill COS and Mikrokill PCC, were developed and launched in record time and have already generated significant customer interest.”

Another preservative, Cosmocil CQ, a bactericide that originally replaced thimersol in contact lens solutions, came to Arch when the firm bought Avecia’s biocide business last year. Lastly, Arch markets Biovert, a highly effective antimicrobial based on the same natural protection factors found in human saliva and tears. All of these systems can be used in all major markets around the globe.

Last month, Lonza introduced Natrulon GPS (global potentiator series). It uses hurdle technology and other potentiation approaches and works with traditional ingredients to improve formulation integrity in order to minimize microbial growth. The naturally derived components of the Natrulon GPS series are multifunctional, providing additional benefits such as moisturization to formulations.

Formulation Challenges

In their haste to roll out all things natural, marketers often neglect to test these products to ensure that the preservative system is adequate.

“The continuing increase in natural and botanical-type raw materials means more introduction of organisms and more nutrients for microorganisms,” observed Pat Lutz of Mason Chemical.

Without an effective preservation system, beauty formulas wouldn’t be so pretty.

To address these problems, Mason offers products such as Maguard H-55 (DMDM Hydantoin), new patent-pending preservatives such as Maguard H-55EX (DMDM Hydantoin plus Quaternary Fluorosurfactant) and enhancement type products such as the Enhansys line of naturally derived fortifying agents.

Other suppliers have gone to extraordinary lengths to embrace the all-natural challenge. Bio-Botanica, for example, enlisted the services of professional herbalist/nutritionist Ellen Kamhi, PhD RN, who calls herself “The Natural Nurse” and is the author of The Natural Medicine Chest.

“Due to the startling rise in the cancer rate, more consumers are looking into the connection between the toxicity of preservatives and other chemical additives and their connection to cancer,” insisted Dr. Kamhi. “In addition, there is a growing awareness about the absorption of products through the skin. This knowledge is being used by the pharmaceutical industry to deliver various drug therapies, such as hormones, and by skin care companies to increase collagen. Paraben-free is becoming a major sales buzzword and is increasing interest in natural preservatives.”

“In the case of parabens, as well as some other traditional preservatives, publication of various technical articles, for example, have led to some quick perception changes. This in turn has led to immediate reactions by some consumer product formulators to replace such chemistries,” said Mr. Cappabianca. “The result is an increasingly fragmented global preservative market. Some formulators expect ‘paraben-free’ now, while others await any regulatory changes regarding parabens and other traditional preservatives, particularly in Europe.”

Fighting Back

“We are being asked to offer paraben alternatives in the raw materials we offer to the industry,” she explained. “Many companies are not using paraben preservatives in the new formulations they are developing.”

As cries for paraben-free products grow louder, the industry has teamed up with the Cosmetic, Toiletry and Fragrance Association (CTFA) to defend this widely used class of preservatives.

According to Stephen O’Connor, Clariant’s R&D manager, personal care, North America, the task force has submitted updated studies to the Cosmetic Ingredient Review in the U.S., the Scientific Committee on Cosmetic Products (SCCP) in Europe and Agence Française de Sécurité Sanitaire des Produits de Santé (AFSSPS) in France.

Based on these results, the Cosmetic Ingredient Review Expert Panel reviewed parabens at their meetings in December 2005 and concluded that all of the parabens included in the review (methylparaben, ethylparaben, propylparaben, butylparaben, isopropylparaben, isobutylparaben and benzylparaben) were “safe as used.”

“The AFSSPS has published the results of their review on parabens, too,” said Mr. O’Connor. “The conclusions are that methylparaben, ethylparaben, propylparaben and butylparaben are safe as currently regulated under the Cosmetics Directive. Additional data on isobutylparaben were requested in order for AFSSAPS to be able to give this ingredient a clean bill of health.”

According to Mr. O’Connor, in January, 2005, the SCCP published an opinion that methylparaben and ethylparaben are safe and the regulation in Europe remains unchanged.

“Based on the latest information from AFSSPS and CIR, it is expected that the SCCP will decide similarly,” he added. “The final CIR report is also expected very soon.”

Despite these reassuring verdicts, the volatility of public opinion has led many preservative suppliers to investigate non-traditional materials for preservation. For example, Schülke & Mayr’s Sensiva SC 50 (INCI: ethylhexylglycerin) is a glyceryl ether that is widely used to boost preservative efficacy, while adding humectancy and a pleasant skin-feel to formulations. It has been shown to significantly improve the broad-spectrum efficacy of both traditional preservatives, such as phenoxyethanol, and many of the new non-traditional methods of preservation available today. According to Linda Sedlewicz, Sensiva SC 50 allows for global formulation and has recently received approval by the Therapeutic Goods Admin-istration (TGA) of Au- stralia for use in sunscreen and other topical drug products.

Elsewhere, Mr. Cappabianca told Happi that Japanese authorities have reached a decision and will approve IPBC for cosmetic use by the middle of the year.

“This vote of confidence will have a positive impact on the use of IPBC globally, particularly in Europe, where some fine-tuning of levels and applications of the current ‘positive listing’ there is currently taking place,” he said.

Fast-growing Categories

Obviously, the demand for natural products is driving growth in many household and personal products categories. But at the same time, consumers are demanding convenient, easy-to-use products and that has provided a lift for household and personal care wipes, said Dianne Carmody, business manager, personal care, at Rohm and Haas.

“(But) the proliferation of various kinds of wipes as well as spa-type, anti-aging and ethnic products, and products to protect color-treated hair may contain some atypical ingredients that present unique preservation challenges,” she warned. “Customers will need preservative suppliers with far-reaching technical expertise and research capabilities to expedite and meet their product development needs.”

At the same time, innovative delivery systems can make the preservation task more difficult than ever. To meet this growing challenge, Schülke & Mayr recently completed testing of Euxyl PE 9010 (INCI: phenoxyethanol [and] ethylhexylglycerin) in a wide variety of different formulation types.

“This testing proves that Euxyl PE 9010 maintains preservative efficacy in both water-in-oil and oil-in-water systems, even after storage at 40°C for three months,” said Ms. Sedlewicz. “It has also been shown to be as effective as traditional phenoxyethanol/paraben blend preservatives in most systems.”

She added that Euxyl PE 9010 can be used to preserve emulsions, clear gels and wipe products.

From wipes to naturals to novel anti-aging ingredients, finished product formulas play an important role in selecting the right preservative system.

New Ideas in Preservation

Mr. Lutz told Happi that Mason has introduced several new preservatives and is enhancing antimicrobial products. New ones such as Maguard I-10L, 10% liquid iodopropropynyl butylcarbamate in glycereth 2-cocoate, for easier solubility and a milder carrier system. Also new is Maguard H-55EX, a patent-pending, broad-spectrum, water-soluble, multifunctional preservative system. In addition, Mason will be introducing Masurf FQ20, a new surfactant for enhancing a formulation’s antimicrobial properties and making it self-preserving.

According to Melissa Frischling, VP-marketing, Lipo Chemicals, Inc. is currently working on a natural, stabilized, mineral-based preservative system.

“Studies are showing broad-based microbial, yeast and mold effectiveness,” said Ms. Frischling. “This, soon-to-be-released, new preservative system may be a natural mineral replacement for paraben.”

Bio-Botanica has developed three natural preservatives that promoted as natural preservatives with considerably low MIC. Available under the tradenames Biopein, Neopein and Suprapein, they have an MIC of 0.2, 0.55 and 0.45%, respectively.

“If companies prefer, they can list the individual herbs that are in the formulas as ‘other ingredients’ and then refer to their product as ‘preservative free,’” explained Em. Youssef Mirhom, Ph.D. VP-R&D, Bio-Botanica, Inc., Haup-pauge, NY. “These natural preservatives can be used for skin care products, toothpastes and mouthwashes, shampoos and deodorants. They are effective in a wide range of pH, both acidic and weakly alkaline,” he added.

Mr. Blinder told Happi that TRI-K is continually searching for natural sources with preservative effects. Last year, the company introduced Hinokitiol, a preservative derived from a Japanese cedar tree.

Many cosmetic manufacturers are now focusing on using organic acid-based preservatives, according to Ms. Sedlewicz. She explained that the consumer views these materials as food preservatives and is often more comfortable with this class than materials that sound more “chemical.” Earlier this year, Schülke & Mayr launched an organic acid preservative blend, Euxyl K701, a combination of phenoxy-ethanol, benzoic acid, dehydroacetic acid and ethylhexylglycerin. This material is globally approved for use in both leave-on and rinse-off products. With the addition of Euxyl K 701, Schülke & Mayr now has four orgainic acid-based preservative systems available for different product applications.

The ‘Softer Side’ of Preservatives

Rohm and Haas is also exploring both “soft” preservatives; e.g., many of the organic acids and “natural” preservatives, said Ms. Carmody. She noted too that most customers admit that formulating with naturals is not easy.

“For example, achieving the right level of preservation may require adding several natural preservatives together to strive for the optimal efficacy,” said Ms. Carmody. “Natural preservatives today are still predicated on what is possible within the realm of ingredients used in products today.”

Ms. Sedlewicz said Schülke & Mayr’s most inovative product, Euxyl PE 9010 (INCI: phenoxyethanol [and] ethylhexylglycerin), addresses the market’s requirement for safety and global acceptance. Recent testing performed on Caucasian skin in Europe and Asian skin in Japan has proven this material to be non-irritating. It is globally approved, including in Japan, and contains chemistries shown to be extremely safe and effective.

Consumer concerns about preservatives continue to grow, but innovative suppliers continue to roll out novel systems to meet the needs of personal care and household product formulators.